Description

Darifenacin is a high-purity pharmaceutical active ingredient, a potent and selective muscarinic M3 receptor antagonist. Its primary commercial value lies in its critical role as the key active component in prescription medications for the treatment of overactive bladder (OAB). This compound is essential for pharmaceutical manufacturers and research institutions engaged in the development and production of urological therapeutics and novel antimuscarinic agents.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of extended-release tablets for the treatment of overactive bladder syndrome, reducing symptoms of urinary urgency, frequency, and incontinence.
• Research & Development: Serves as a key reference standard and building block in pharmacological research focused on muscarinic acetylcholine receptors and urinary tract physiology.
• Generic Drug Manufacturing: Critical for companies producing generic versions of darifenacin-based medications, ensuring bioequivalence and therapeutic efficacy.
• Preclinical Studies: Utilized in animal models to study the pharmacokinetics, pharmacodynamics, and safety profile of antimuscarinic therapies.
• Analytical Standard: Used in quality control laboratories for HPLC, LC-MS, and other analytical methods to assay drug products and raw materials.

Basic Information

Product Name	Darifenacin
CAS No.	133099-04-4
Molecular Formula	C28H30N2O2
Molecular Weight	426.55 g/mol
Synonyms	(S)-2-{1-[2-(2,3-Dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide; Darifenacin Hydrobromide (salt form precursor); UK-88,525; Enablex® (Brand Name); 7-[(1S)-2-({(2S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-2-yl}carbonyl)-1-phenylethyl]-1-methyl-3,7-dihydro-1H-purine-2,6-dione (IUPAC alternative); Selective M3 Muscarinic Receptor Antagonist
EINECS	Contact for details

Quality Control

Our Darifenacin is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing including identification, assay, impurity profiling (related substances), residual solvents, and heavy metals to ensure it meets stringent pharmaceutical standards. A Certificate of Analysis (COA) detailing all test results against relevant specifications is provided with every shipment to guarantee traceability, purity, and consistency for our global customers.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Specific Rotation	Contact for details

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.